India: CDSCO Advises Strict Regulation Of Oxytocin To Curb Its Misuse

Oxytocin is a neuro-hormone and neurotransmitter normally produced by the paraventricular nucleus of the hypothalamus and released in large amounts by the posterior pituitary gland in mammals. Oxytocin is known to induce contractions of the uterus during labour, and stimulate the ejection of milk during breastfeeding. Oxytocin also known as love-hormone as it plays a role in the female reproductive functions including sexual activity, child birth and maternal nurturing behavior along with general psychological stability.

In this view, synthetic Oxytocin is being widely administered in obstetric practice for induction of labour, control of bleeding following delivery and for stimulation of milk letdown reflex in human and cattle as well. However, people have started using Oxytocin injections unsystematically on milch animals not only during delivery of a calf, but more frequently to accrue greater benefit/profit - for example a milch cattle is injected 5 ml of Oxytocin twice a day just five minutes prior to milking so that milk flows out faster from the udder7.

The Central Drug Standard Control Organization (CDSCO) observed many complaints regarding misuse of Oxytocin injection by dairy owners in milch cattles and by farmers to increase the size of vegetables and fruits. However, no scientific data on the support of such practices is available. According to the "National Dairy Research Institute (NDRI)" and "Indian Council of Agricultural Research (ICAR)" there is no scientific evidence that artificial use of Oxytocin has adversely affected progeny of cattle and buffaloes resulting in dwindling of livestock. However, continuous Oxytocin use could lead to a progressive addiction and lack of response to normal let down of milk8.

Central government restricts manufacture, sale and distribution of Oxytocin

On January 17, 2014, Ministry of Health and Family Welfare (MoHFW) issued a notification under Section 26A of the Drugs and Cosmetics Act, 1940 restricting the manufacture and sale of Oxytocin thereunder:

  • The manufacturers of bulk Oxytocin drug shall supply the active pharmaceutical drug only to the manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug.
  • The formulations meant for veterinary use shall be sold to the veterinary hospitals only9.

Further, the Department of Animal Husbandry, Dairying and Fisheries have also issued an advisory to all the State Governments to comply with the provisions of the above-mentioned notification. Despite this, continued misuse of Oxytocin injection in the country has been considered by the Drug Consultative Meeting (DCC) as well as Drug Technical Advisory Board (DTAB) in its various meetings. The problem of misuse of Oxytocin is related more to the degree of control over the manufacture and sale of the drug especially through clandestine channels.10

CDSCO's strict regulatory control over manufacture, sale and distribution of Oxytocin

On September 22, 2017, CDSCO, with the intimation of Ministry of Health and Family Welfare (MoHFW), has directed all state drug controllers regarding strict regulatory control over manufacture, sale and distribution of Oxytocin and to curb its misuse as described below-

I. Constitution of special task force in each District of each State to ensure that no prohibited/regulated drug including Oxytocin is freely available in any district in open market, save and except in the pre- cribed manner.

II. Concerned State Drug Controllers of the States where licenses of manufacturing of Oxytocin have been issued shall examine the license of all existing manufacturers of Oxytocin to ensure that the same have been issued strictly in accordance to the Drug and Cosmetic Act, 1940 and Rules 1945 and that the manufacturers mandatorily comply with all the conditions of the Act and rules framed there under. Immediate appropriate actions as per the statutory provisions may be taken wherever violations of the rules are found.

III. The State Drug controllers shall place on their respective websites, by 10th of each month, details of licenses issued to various manufacturers along with the monthly statement of production and sales of Oxytocin with complete particulars and details submitted by manufacturers. The manufacturers of Oxytocin, shall in turn, submit these details beforehand so as to reach the office of drug Controller by 7th of every month.

IV. The wholesaler and retailers of all prohibited scheduled drugs including Oxytocin shall maintain records, as required under law and the same shall be produced for inspection after every quarter before the officer specifically deployed for this purpose by drug controller.

V. The State Drug Controllers may take appropriate steps for undertaking IEC activities for sensitizing public about ill effects of Oxytocin both on humans and on animals' especially milch cattle, and about penal provisions for abuse/misuse of Oxytocin11.

On February 22, 2018, CDSCO met with all manufacturers of oxytocin to discuss illegal manufacture, import and sale of oxytocin and its misuse. Further, CDSCO on February 28, 2018, has released proposals via public notice requesting comments/suggestions from stakeholders in this regard. The CDSCO's notice says that "As the whole issue of Oxytocin is of paramount importance for protection of human and animal health, following proposals are under consideration to curb its misuse:

I. To prohibit the import of the Oxytocin and its formulations for human use as well as animal use under section 10A of the Drugs and Cosmetics Act, 1940.

II. To regulate and restrict the Oxytocin formulations for human use under Section 26A of the Drugs and Cosmetics Act, 1940, so that the drug is supplied only to registered hospitals and clinics in public and private sector.

III. To adopt bar-coding system for manufacture of Oxytocin formulations so as to ensure trackability and traceability of the product to avoid its misuse.

IV. Manufacturing of Oxytocin (formulation) shall be restricted in public sector units only". However, above proposals shall not be applicable for Oxytocin meant for export purpose12.

Conclusion:

The manufacture, sale and distribution of Oxytocin are well described under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. However, a strict vigilance and regular monitoring/inspection of Oxytocin misuse by Central and state drug authorities are recommended. As per CDSCO's Data bank updated earlier in February this year, there are 3 registered bulk manufacturers and 113 formulation manufacturers of Oxytocin in India.

Footnotes

7 http://www.bwcindia.org/Web/Awareness/LearnAbout/Oxytocin.html

8 http://dahd.nic.in/sites/default/files/LS%20328.pdf

9 http://cdsco.nic.in/writereaddata/G.S.R.%2029%20(E).pdf

10 http://www.cdsco.nic.in/writereaddata/70th%20DTAB%20minutes.pdf

11 http://www.cdsco.nic.in/writereaddata/notice22_9_2017.pdf

12 http://www.cdsco.nic.in/writereaddata/Public%20Notice28.pdf

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